FDA advisers recommend approval of new gout drug

WASHINGTON (AP) -- Government health advisers have recommended
approval of the first new drug in 40 years for gout, a painful
joint disease that mainly strikes middle-aged men.

About 5 million people in the U.S. suffer from gout, a form of
arthritis caused by a build-up of uric acid in the blood. Uloric,
as the new drug is called, works by reducing levels of uric
acid.

In healthy people, uric acid is dissolved in the blood and
excreted from the body in urine. But high levels lead to the
formation of needle-like crystals that become deposited in the
joints, causing intense pain and swelling. Many patients experience
their first attack of gout in the big toe. The disease can
progress, causing deformities.

Food and Drug Administration medical reviewers were concerned
because early trials of Uloric found a higher risk of death and
heart problems from the drug. But Takeda Inc., which makes Uloric,
commissioned a much larger clinical study that found no difference
in heart risks when compared with the currently available drug,
allopurinol.

Takeda said its medication works better for patients with kidney
problems. "A lot of gout patients suffer from kidney disease," said
Dr. Nancy Joseph-Ridge, head of research and development for the
company. "This is something of real need. Patients who could not
take the other drug will now have treatment."

The FDA arthritis advisory committee voted 12-0 to recommend
approval of Uloric for chronic gout. One member abstained. The FDA
usually follows the recommendations of its advisers.